BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2780022 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12737
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 29, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ON VISUAL INSPECTION, THERE WAS DRIED BLOOD OR BODY FLUID NOTED IN THE LEAD LUMEN. ALSO, ELECTROCAUTERY MELTED INSULATION WAS OBSERVED AT 79, 182, 203, 425, AND 675 MM FROM THE TERMINAL PIN; AT 835 MM FROM THE TERMINAL PIN THE INSULATION WAS BUNCHED. THE INSULATION ISSUES ARE CONSISTENT WITH INDUCED DAMAGE FROM THE EXPLANT PROCEDURE. RESISTANCE TESTING WAS COMPLETED TO ASSESS THE LEAD'S ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES THAT WOULD CAUSE A DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS WITH LOSS OF CAPTURE NOTED. IT WAS DETERMINED THE LEAD WAS DISLODGED AND SUBSEQUENTLY SURGICAL INTERVENTION WAS PERFORMED. THIS LEAD WAS EXPLANTED AND A NEW LV LEAD WAS SUCCESSFULLY PLACED IN A DIFFERENT BRANCH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R 4542| 4136| 0181| N119| 4592